A major problem in relation to drug preparation, drug administration or other similar handling of pharmaceuticals is the risk of medical and pharmacological staff being exposed to drugs or solvents which may escape into ambient air. The problem is particularly serious when cytotoxins, antiviral drugs, antibiotics and radiopharmaceuticals are concerned. Other hazards may arise when taking samples relating to virus infections or the like.
Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle for example. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial if any pressure differential between the interior of the vial and surrounding atmosphere exists.
For these reasons, systems for handling and administrating drugs and other medical substances under improved safety conditions have been developed.
U.S. Pat. No. 4,564,054 (Gustavsson) discloses a fluid transfer device for preventing air contamination when transferring a substance from one vessel to a second vessel. The device is attached or connectible to the vessel and comprises a first member, in which a piercing member such as a hollow needle is enclosed. The first member has a sealing member through which the needle can be passed. The device further comprises a second member, which is detachably connectable to the first member and which also comes a sealing member. When the first and second members are connected to each other, the two sealing members are located in a position with respect to each other so that they can be penetrated by the piercing member which is movable with respect to the sealing member.
The sealing members used in the high-security transfer and connecting devices disclosed herein are flexible and elastically compressible liquid and gas-proof membranes, also known as barriers or septums which have the ability of sealing tightly after penetration and retraction of a piercing member in order to prevent escape of liquid as well as gas components.
Commonly used sealing members are made from a thermoplastic elastomeric polymer material (TPE) allowing the members to be affixed in a connecting device by thermal welding, such as ultrasonic welding.
The medical transfer and connecting devices are designed for repeated and intermittent, use, for example when removing individual doses of a pharmaceutical from a vial or when connecting an injection device to a catheter, IV-equipment, or similar. It is not uncommon that each transfer and connecting device is used many times, such as up to 10 times, before eventually being discarded or replaced. After use, the device may often be left with the sealing member exposed to the environment for several hours before the next instance of use. The connecting devices are used in non-aseptic environments and in environments where the risk of contamination with bacteria and other hazardous matter may be high such as in hospital wards. As the connecting devices may be used for a long time under such conditions, a risk for bacterial growth on the sealing member is imminent. Accordingly, it is highly desirable that the device and in particular the sealing member, in the device be cleaned before each new use, in particular if a longer time period has lapsed since the last use. Without adequate cleaning of the sealing member before use, there is a risk that bacteria enters into the medical transfer system and is eventually transferred to a patient causing suffering and increased medical expenses.
Accordingly, there is a need for a medical transfer and connecting device for use in medical equipment involving handling of fluids such as pharmaceuticals, which transfer and connecting device can be easily and efficiently cleaned.